BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 3942269 · Received July 17, 2014

    Report

    Report Number
    1416980-2014-23065
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Report Date
    June 24, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT WAS BORN IN 1955. THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: COMBINATION PRODUCT, MANUFACTURE DATE: MARCH 12, 2013 ¿ MARCH 13, 2013. EVALUATION: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS RECEIVED FOR EVALUATION WITH APPROXIMATELY 70 ML OF FLUID WITHIN ITS BLADDER. NO FLOW WAS OBSERVED WHEN THE LUER CAP WAS REMOVED FROM THE DISTAL LUER. VISUAL INSPECTION REVEALED A CRYSTALLIZED SUBSTANCE BLOCKING THE FLUID PATHWAY AT THE END OF THE GLASS CAPILLARY. THE REPORTED PROBLEM WAS VERIFIED. THE CAUSE OF THE PROBLEM IS UNKNOWN. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMALL VOLUME FOLFUSOR HAD NO FLOW. THE DEVICE WAS FILLED WITH 4750MG OF FLUOROURACIL AND NORMAL SALINE, TOTALING 100ML OF SOLUTION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419286 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14C037

    Patients

    Seq Age Sex Outcome Treatment
    1 NORMAL SALINE| FLUOROURACIL